QA Engineer, DSM Ops | Drug Substance Manufacturing

FUJIFILM Biotechnologies; Holly Springs (NC); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Engineer for the DSM Operations program. This role provides quality oversight of DSM processes from development through startup and into commercial operation, ensuring validated state and lifecycle compliance across systems.

The 2-2-3, 6am-6pm schedule supports manufacturing continuity and regulatory readiness. Key responsibilities include reviewing and approving qualification protocols, validation plans, risk assessments, and cGMP

Formación

• BS/BA in Life Sciences or Engineering with 5+ years in industry or MS with 3+ years; or PhD with 1+ year.
• 3+ years of GMP-regulated experience in validation or QA oversight.
• Experience with validation of production equipment and equipment lifecycle.
• Familiarity with FDA 21 CFR Part 820 and Part 11 is preferred.

Responsabilidades

• QA SME role for DSM program documents, processes, and procedures.
• Oversee change management and ensure validated state through startup to commercial operation.
• Approve lifecycle documentation, risk assessments, specifications, and validation reports.
• Develop and approve QA procedures for validation approaches.
• Support QA readiness objectives and manufacturing operations in cGMP facility.
• Collaborate with FUJIFILM sites to streamline processes and improve efficiency.
• Assist in regulatory inspections and quality improvement initiatives.

Conocimientos

Verbal communication

Written communication

Time management

Critical thinking

Problem solving

Cross-functional collaboration

Quality systems

GAMP5 knowledge

Validation knowledge

Educación

BS/BA Life Sciences or Engineering

MS Life Sciences or Engineering

PhD Life Sciences or Engineering

GMP/regulatory experience

Herramientas

Smartsheet

Trackwise

MasterControl

Kneat validation software

Descripción del empleo

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Engineer for the DSM Operations program. This role provides quality oversight of DSM processes from development through startup and into commercial operation, ensuring validated state and lifecycle compliance across systems.

The 2-2-3, 6am-6pm schedule supports manufacturing continuity and regulatory readiness. Key responsibilities include reviewing and approving qualification protocols, validation plans, risk assessments, and cGMP